Status:
COMPLETED
Anti-thymocyte Globulin and Cyclosporine as First-Line Therapy in Treating Patients With Severe Aplastic Anemia
Lead Sponsor:
The Cleveland Clinic
Conditions:
Aplastic Anemia
Eligibility:
All Genders
12+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Immunosuppressive therapies, such as anti-thymocyte globulin and cyclosporine, may improve bone marrow function and increase blood cell counts. PURPOSE: This phase II trial is studying how ...
Detailed Description
PRIMARY OBJECTIVES: To determine the response rate of r-ATG and CsA in the first line setting. SECONDARY OBJECTIVES: To determine the level of IS as assessed by Immuknow assay in responders and compar...
Eligibility Criteria
Inclusion
- All patients with sAA as defined by Camitta who are candidates for IS therapy; these criteria include bone marrow cellularity \< 25% or 25-50% with \< 30% of hematopoietic cells; it should also have two of the following three parameters: peripheral blood neutrophils \< 0.5 x 10\^9/L, platelets \< 20 x 10\^9/L and reticulocytes \< 60 x 10\^9/L in anemic patients
- If cytogenetic testing has been done, it should show normal karyotype or be not informative
- Patients should be either unwilling or otherwise ineligible (age, comorbidities, lack of donor) for bone marrow transplantation as a therapeutic modality
- Not previously treated with ATG for sAA
- Patients must have ECOG performance status of 0, 1, or 2
- Vitamin B12 and folic acid deficiency must be ruled out by measurement of serum levels
- Patients must have had a bone marrow biopsy examination in the three months prior to enrolling in the study
- Must be able to provide informed consent
- Systemic and other hematologic causes of pancytopenia, based on clinical presentation, must have been ruled out
Exclusion
- Patients with clinically evident congestive heart failure, serious cardiac arrhythmias; symptoms of coronary artery disease must be cleared by cardiology prior to therapy
- Patients who have had chemotherapy, radiotherapy, or immunotherapy or other investigational drug use within 3 weeks prior to study entry
- Pregnant women
- All females of childbearing potential must have a blood test or urine study within two weeks prior to induction registration to rule out pregnancy
- Women of childbearing potential are strongly advised to use an accepted and effective method of contraception
- Patients who have medical, psychological, or social conditions that may interfere with the patient's participation in the study or evaluation of the study results
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2010
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01231841
Start Date
March 1 2005
End Date
December 1 2010
Last Update
June 22 2023
Active Locations (1)
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1
Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195